Job Description At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science.
In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change.
We bring a human touch to every treatment we pioneer.
Join us and make a difference.
The Senior Principal Scientist will be a drug product analytical lead who will champion small molecule drug products development activities that includes analytical method development, characterization of drug product formulation and formulation/process development.
The Sr.
Principal scientist will be an integral part of drug product development group and will provide necessary guidance and support of drug product control strategy for drug candidates across all stages of development and, as needed, within our commercial product portfolio.
He/she will be proficient in the latest ICH, FDA and EMA regulatory guidance on pharmaceutical development.
He/she will be a member of a cross functional team responsible for drug product analytical related CMC strategy development.
Senior Principal Scientist will be an individual contributor and leader of a matrix team of analytical scientists.
They will collaborate across BMS sites with Analytical, Drug Product, Quality, and Regulatory leads to generate and execute drug product formulation/process development support, analytical strategies for drug product methods and specifications, analytical control strategies, and support of product development up to drug application submissions and approval.
Responsibilities: Execute drug product formulation and process development including characterization of the process and finished product.
Develop, optimize, analytical method and provide guidance during validation and transfer.
Conduct and assess developmental stability experiments to inform packaging selection for drug products.
Provide leadership and supervision to scientific staff.
Develop, coach and mentor others.
May serve on a cross functional team responsible for analytical related CMC strategy development.
Review and discuss analytical results and conclusions both orally and in writing.
Write formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
Requirements: Completed BS and minimum of 12 years; MS minimum of 10 years; or Ph.D.
and minimum of 8 years in Chemistry (or relevant discipline) with pharmaceutical laboratory experience.
A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
Understands PAT, risk assessment, and chemometrics.
Experience in formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development Mastery of chemistry with extensive expertise in measurement science.
Experience in the development and performance of analytical tests for a variety of drug products dosage forms.
Knowledge of dissolution method development and testing, and biopharmaceutical classification system.
Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer.
Ideal Candidates Would Also Have: Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
Familiar with modern laboratory equipment and automation.
Understands and applies Quality by Design principles